美諾孕多劑量600國際單位

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

Menotrophin HP

可用日期:

輝凌藥品股份有限公司 台北市中山區松江路111號11樓 (86386138)

ATC代码:

G03GA

药物剂型:

注射劑

组成:

主成分 (凍晶乾粉注射劑(每小瓶含):) ; Menotrophin HP (6818001020) IU

每包单位数:

/vial;;1ml預充填針筒 + 1支調配用針頭 + 9支裝有注射用針頭的拋棄式針筒

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

ZUELLIG PHARMA SPECIALTY SOLUTIONS GROUP PTE. LTD. 15 CHANGI NORTH WAY #01-02, #02-02, #02-10, SINGAPORE 498770 SG

治疗领域:

Gonadotropins

疗效迹象:

(1)對clomiphene citrate治療無反應之無排卵症不孕婦女，包括：多囊性卵巢症(polycystic ovarian disease)。(2)接受人工協助生殖技術之婦女，於受控制下刺激卵巢，以誘發多個濾泡的發育(如 體外授精、配子輸卵管植入和單精子胞漿內注射。

產品總結:

有效日期: 2028/01/15; 英文品名: MENOPUR multidose 600IU

授权日期:

2013-01-15

资料单张

MENOPUR
®
MULTIDOSE 600 IU
MENOPUR
® MULTIDOSE 1200 IU
QUALITATIVE AND QUANTITATIVE COMPOSITION
MENOPUR
®
multidose 600 IU: Each vial with powder contains
highly purified menotrophin (human menopausal gonadotrophin,
HMG) corresponding to follicle stimulating hormone activity FSH
600 IU and luteinizing hormone activity LH 600 IU.
MENOPUR
®
multidose 1200 IU: Each vial with powder contains
highly purified menotrophin (human menopausal gonadotrophin,
HMG) corresponding to follicle stimulating hormone activity FSH
1200 IU and luteinizing hormone activity LH 1200 IU.
Human Chorionic Gonadotrophin (hCG), a naturally occurring
hormone in postmenopausal urine, is present in MENOPUR
®
and
is the main contributor of the LH activity.
For the full list of excipients, see section List of excipients.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of powder: white to off-white lyophilisation cake
Appearance of solvent: clear colourless solution
THERAPEUTIC INDICATIONS
(1) Anovulation, including polycystic ovarian disease (PCOD), in
women
who
have
been
unresponsive
to
treatment
with
clomiphene citrate.
(2)
Controlled
ovarian
hyperstimulation
to
induce
the
development
of
multiple
follicles
for
assisted
reproductive
technologies
(ART)
(e.g.
in
vitro
fertilization
(IVF)),
gamete
intra-fallopian
transfer
(GIFT)
and
intracytoplasmic
sperm
injection (ICSI).
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment
with
MENOPUR
®
should
be
initiated
under
the
supervision of a physician experienced in the treatment of fertility
problems.
Method of administration
MENOPUR
®
is intended for subcutaneous (S.C.) injection or
Intramuscular injection (I.M.) after reconstitution with the solvent
provided.
The
powder
should
be
reconstituted
prior
to
use.
The
reconstituted solution is for multiple injections and can be used
for up to 28 days.
Each vial of reconstituted solution of 600 IU /1 ml or 1200 IU /2 ml
is only allowed to be used for one single individual patient.
Vigorous shaking should be avoided. The solution